Physical Activity in Relation to Surgical Procedures

Not Applicable

Active, not recruiting

• Conditions: Surgery; Colorectal Cancer

• Registration Number: NCT02299596
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.

Detailed Description

The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.

A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.

Study Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2015-01
• Primary Completion: 2020-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 761

Inclusion Criteria

• Diagnosed colorectal cancer and a planned surgical procedure

Exclusion Criteria

• HIPEC surgery, not able to give informed consent or understand the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recovery measured as physical recovery measured in questionnaire	4-6 weeks

Secondary Outcome Measures

Name	Time	Method
Complications according to Clavien-Dindo	within 90 days	Postoperative complications
QoL measured using EQ-5D	4-6 weeks and 1 year	QoL according to EQ-5D
Psychological recovery measured in a questionnaire, patient reported	4-6 weeks and 1 year post-operatively	Recovery
QoL measured using a specifically developed instrument for this study	4-6 weeks and 1 year	Health related QoL
Total time of hospital stay	1 year	Length of stay
Mortality	3 and 5 years	Long term mortality
Re-admissions	1 year	Hospital re-admissions
Reoperations	1 year	Reoperations
Recovery measured as time back to work	1 year	Recovery
QoL measured using SF-36	4-6 weeks and 1 year	QoL according to SF-36
IGF-1 and IGFBP-3	4 weeks postopeartively	Lab values
Postoperative pain measured with Brief Pain Inventory-Short form	12 months	Pain measured by BPI-S
Health economic analysis	12 months	Health economic analysis modified according to results of primary outcome

Trial Locations

Locations (2)

Sahlgrenska University Hospital/Östra; 🇸🇪 Göteborg, Sweden

Dept. of Surgery, Skaraborgs Sjukhus; 🇸🇪 Skövde, Sweden